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EXHIBIT 10.1
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Portions of this Exhibit 10.1 have been redacted and are the subject of a
confidential treatment request filed with the Secretary of the Securities and
Exchange Commission
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Exhibit 10.1
COLLABORATIVE RESEARCH AGREEMENT
This COLLABORATIVE RESEARCH AGREEMENT is entered into as of
December 31, 1991 by and between AMERICAN HOME PRODUCTS CORPORATION, a
corporation of the State of Delaware, U.S.A. , having its principal place of
business at 685 Third Avenue, New York, New York 10017, U.S.A. , as represented
by its agent, Wyeth-Ayerst Laboratories Division (hereinafter collectively
referred to as "Wyeth") and ONCOGENE SCIENCE, INC. (hereinafter referred to as
"OSI"), a corporation of the State of Delaware, having its principal place of
business at 106 Charles Lindbergh Blvd., Uniondale, New York 11553, U.S.A.
WHEREAS, OSI was organized to develop, produce and market therapeutic
and diagnostic products for the treatment and early detection and monitoring of
human disease; and
WHEREAS, OSI has developed proprietary gene transcription and gene
expression modulation technology and high throughput screening systems which may
be used to identify and develop novel transcription-based drugs; and
WHEREAS, Wyeth has the capability to undertake research for the
discovery and evaluation of agents for the treatment of disease and also the
capability for clinical evaluation, manufacturing and marketing of such agents;
and
WHEREAS, WYETH and OSI wish to enter into a collaborative research
agreement to identify and develop transcription-based drugs;
NOW, THEREFORE, the parties agree as follows:
1. Definitions.
Whenever used in this Agreement, the terms defined in this Section 1 shall have
the meanings specified.
1.1. "Affiliate" means any corporation or other legal
entity owning, directly or indirectly, fifty percent or more of the voting
capital shares or similar voting securities of Wyeth or OSI; or any corporation
or other legal entity fifty percent or more of the voting capital shares or
similar voting rights of which is owned, directly or indirectly, by Wyeth or
OSI.
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1.2. "Annual Commitment" means the amount to be paid to
OSI by Wyeth to fund the Sponsored Research Program for any Commitment Year.
1.3. "Allocated Overhead" means the amount of overhead,
including general and administrative costs, determined in accordance with
generally accepted accounting principles, incurred by OSI and allocated to the
Sponsored Research Program in the same proportion that the total man-hours of
work performed in the Sponsored Research Program bears to the total man-hours of
work performed in all OSI research programs, or such other customary allocation
basis that may be agreed in writing between the parties.
1.4. "Annual Research Plan" means the written plan
describing the annual research concerning the Targets (including budgets) to be
carried out during each Commitment Year by OSI and Wyeth pursuant to this
Agreement, including both the Annual Sponsored Research Plan to be carried out
by OSI and the specific projects, timetables and technical goals to be pursued
by Wyeth and OSI.
1.5. "Annual Sponsored Research Plan" means the written
plan describing the research concerning the Targets to be carried out during
each Commitment Year by OSI pursuant to this Agreement, including the specific
projects, timetables and technical goals to be pursued by OSI. The Annual
Sponsored Research Plan for Commitment Years 1 and 2 is appended hereto as
Exhibit 1.
1.6. "Research Program" is the collaborative research
program concerning the Targets that is to be conducted by Wyeth and OSI.
1.7. "Sponsored Research Program" is that part of the
Research Program that is to be carried out by OSI.
1.8. "Effective Date" is _________________________, 19__.
1.9. "Target(s)" means each of those proteins identified
as a drug development target in the Annual Sponsored Research Plan appended to
this Agreement as Exhibit 1 concerning which proteins research projects will be
conducted to identify lead compounds from which transcription-based drugs may be
developed or derived, including all therapeutic indications identified in the
course of such research projects.
1.10. "Contract Period" means the period beginning on
the Effective Date and ending on the date on which this Agreement terminates.
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1.11. "Commitment Year" means a twelve-month period
terminating on each anniversary of the Effective Date.
1.12. "Technology" means and includes all technology and
technical information concerning a Target that pertains to the development of
human therapeutic products, including all laboratory notebooks, research plans,
inventions, cultures, strains, vectors, genes and gene fragments and their
sequences, cell lines, hybridoma cell lines, monoclonal and polyclonal
antibodies, proteins and protein fragments, non-protein chemical structures and
methods for synthesis, structure-activity relationships, computer models of
chemical structures, computer software, assay methodology, processes, materials
and methods for production, recovery and purification of natural products,
formulas, plans, specifications, characteristics, equipment and equipment
designs, marketing surveys and plans, business plans, know-how, experience and
trade secrets.
1.13. "OSI Technology" means all Technology that pertains
to a Target and relates to transcriptional modulation of gene expression of the
gene encoding the Target, including all improvements thereto and the use of such
Technology to develop transcription-based drugs, that is or was:
(a) developed by employees of, or consultants
to, OSI alone or jointly with third parties including Wyeth;
or
(b) acquired by purchase, license, assignment or
other means from third parties by OSI. OSI Technology shall
include all such Technology other than Wyeth Technology.
1.14. "Wyeth Technology" means all Technology developed
through the use of OSI Technology that pertains to a Target and relates to
specific chemical compounds or drugs or the therapeutic use(s) of such compounds
or drugs, that is or was:
(a) developed by employees of, or consultants
to, Wyeth alone or jointly with third parties including OSI;
or
(b) acquired by purchase, license, assignment or
other means from third parties by Wyeth.
1.15. "OSI Confidential Information" means all information
about any element of OSI Technology which is disclosed by OSI to Wyeth, orally
or in writing, and
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designated "Confidential" in writing by OSI no later than thirty (30) days after
the time of disclosure to Wyeth to the extent that such information as of the
date of disclosure to Wyeth is not (i) known to Wyeth other than by virtue of a
prior confidential disclosure to Wyeth by OSI or (ii) disclosed in the published
literature, or otherwise generally known to the public, or (iii) obtained by
Wyeth from a third party free from any obligation of secrecy to OSI; provided,
however, that such third party has no obligation of confidentiality to Wyeth.
1.16. "Wyeth Confidential Information" means all
information about any element of Wyeth Technology which is disclosed by Wyeth to
OSI, orally or in writing, and designated "Confidential" in writing by Wyeth no
later than thirty (30) days after the time of disclosure to OSI to the extent
that such information as of the date of disclosure to OSI is not (i) known to
OSI other than by virtue of a prior confidential disclosure to OSI by Wyeth or
(ii) disclosed in the published literature, or otherwise generally known to the
public, or (iii) obtained by OSI from a third party free from any obligation of
secrecy to Wyeth; provided, however, that such third party has no obligation of
confidentiality to OSI.
1.17. "OSI Patent Rights" means all applications for
letters patent, whether domestic or foreign, which are encompassed within OSI
Technology, including all continuations, continuations-in-part, divisions,
renewals and patents of addition thereof, all letters patent granted thereon,
and all reissues and extensions thereof.
1.18. "Wyeth Patent Rights" means all applications for
letters patent, whether domestic or foreign, which are encompassed within Wyeth
Technology, including all continuations, continuations-in-part, divisions,
renewals and patents of addition thereof, all letters patent granted thereon,
and all reissues and extensions thereof.
1.19. "Valid Claim" means a claim within OSI Patent Rights
or Wyeth Patent Rights so long as such claim shall not have been disclaimed by
Wyeth or OSI, whichever is appropriate, or shall not have been held invalid in a
final decision rendered by a tribunal of competent jurisdiction from which no
appeal has been or can be taken.
1.20. "Human Therapeutic Product" means any product for the
treatment or management of any disease state in a human patient or any other
human therapeutic indication derived from the Research Program in the course of
research concerning a Target.
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1.21. "Licensed Human Therapeutic Product" means a Human
Therapeutic Product that employs Wyeth Patent Rights, OSI Patent Rights, Wyeth
Technology or OSI Technology in its manufacture, use or sale.
1.22. "Event of Termination" has the meaning set forth in
Section 9.3.
1.23. "Funding Payments" has the meaning set forth in
Section 3.
1.24. "Person" means any individual, estate, trust,
partnership, joint venture, association, firm, corporation, company, or other
entity.
1.25. "Research Committee" has the meaning specified in
Section 2.2.
2. Collaborative Research Program.
2.1.1. Purpose. OSI and Wyeth shall conduct a collaborative
research program concerning the Targets (the "Research Program") throughout the
Contract Period. The Research Program shall include, as a component, a research
program that shall be pursued by OSI and that shall be funded by Wyeth
throughout the Contract Period (the "Sponsored Research Program") . The
objective of the Research Program is to discover and develop Human Therapeutic
Products.
2.1.2. Annual Research Plan. The Annual Research Plan for
the first and second Commitment Years is described in Exhibit 1. Wyeth shall
have the option to extend the Annual Research Plan beyond the second Commitment
Year, which extension shall be on the basis of mutual agreement of the parties.
For each Commitment Year after the first Commitment Year, an Annual Research
Plan shall be prepared by the Research Committee for submission to, and approval
by, Wyeth and OSI no later than sixty (60) days before the end of the prior
Commitment Year. The Annual Research Plan and the Annual Sponsored Research
Plan for each Commitment Year shall be appended to and made part of this
Agreement.
2.1.3. Exclusivity.
OSI agrees that during the Contract Period neither
OSI nor any of its Affiliates shall conduct research itself, or sponsor any
research, or engage in any research sponsored by any Person not a party to this
Agreement, if the objective of such research is to use any Target in the
discovery and development of Human Therapeutic Products.
2.2. Research Committee.
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2.2.1. Purpose. A Research Committee shall be established
by Wyeth and OSI to:
(a) review, coordinate and evaluate progress under the
Annual Research Plan;
(b) prepare the Annual Research Plan including the budget
for each Commitment Year; and
(c) coordinate the OSI and Wyeth programs and the
exchange of information and materials that relate to the Research Program.
2.2.2. Membership. Wyeth and OSI each shall appoint, in
its sole discretion, an equal number of members to the Research Committee.
Substitutes may be appointed at any time.
The members initially shall be:
OSI Appointees: J.G. Foulkes, Ph.D. (Co-Chairperson)
Casey Case, Ph.D. (Research Program Manager)
Collin Goddard, Ph.D.
Wyeth Appointees: Guy Schiehser, Ph.D. (Co-Chairperson)
Catherine Bansbach, Ph.D.
Ling-Sing Chen, Ph.D.
2.2.3. Chair. The Research Committee shall be chaired by
two co-chairpersons, one appointed by Wyeth and the other appointed by OSI.
2.2.4. Meetings. The Research Committee shall meet at
least quarterly, at places and on dates selected by each party in turn.
Representatives of Wyeth or OSI, or both, in addition to members of the Research
Committee, may attend such meetings at the invitation of both parties.
2.2.5 Minutes. The Research Committee shall keep accurate
minutes of its deliberations which record all proposed decisions and all actions
recommended or taken. The minutes shall be delivered to all Research Committee
members within five working days after each meeting. The party hosting the
meeting shall be responsible for the preparation of the minutes. Draft minutes
shall be edited by the co-chairpersons and shall be issued in final form only
with their approval and agreement.
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2.2.6. Decisions. Subject to the provisions of Section
2.1.2, all technical decisions of the Research Committee shall be made by
majority vote of.the members. Business decisions shall be made by the
managements of Wyeth and OSI, in consultation with each other. If the parties
are unable to agree, Wyeth shall have the final say in all technical and
business decisions.
2.2.7. Expenses. Wyeth and OSI shall each bear all expenses
of their respective members related to participation on the Research Committee.
3. Funding Payments.
3.1 The Annual Commitment for the first Commitment Year
is ***. The Annual Commitment for the second Commitment Year is ***.
3.2 Payments by Wyeth to cover OSI's total, actual
research costs, plus Allocated Overhead, (the "Funding Payments") shall not
exceed the Annual Commitment in any Commitment Year, unless mutually agreed upon
by both parties. The Annual Commitment for the second Commitment Year is based
on *** man-years per Target which is the expected average requirement, and is
subject to modification by mutual agreement if an unusually large number of lead
compounds are identified or if additional genetic constructs are required to be
constructed by OSI to facilitate lead development as specified in Exhibit 1.
3.2.1. All Funding Payments shall be made quarterly
in advance for work scheduled to be performed by OSI during any three (3) month
period, against OSI's invoice for such three (3) month period. Adjustments as
necessary to reflect the work actually performed by OSI shall be made at the end
of each three (3) month period and shall be reflected in OSI's invoice for the
next three (3) month period.
3.2.2. The amount of the Funding Payment for each
quarter shall be based on the work in progress pursuant to the applicable Annual
Sponsored Research Plan and the associated annual budget; provided, however,
that the aggregate amount of Funding Payments made in any Commitment Year shall
not exceed the Annual Commitment for such Commitment Year, unless approved in
advance by Wyeth.
3.2.3. Each Funding Payment shall be paid on the
first day of the quarter or ten (10) days after receipt of the applicable
invoice, whichever is later.
*** These portions deleted pursuant to a request for confidential treatment.
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4. Wyeth Rights and Obligations.
4.1. Diligent Efforts. Wyeth and OSI each shall use
reasonably diligent efforts to achieve the objectives of the Research Program.
OSI will use reasonably diligent efforts to pursue the research objectives
described in Exhibit 1 and Wyeth will use reasonably diligent efforts to assist
OSI in the pursuit of those objectives. To achieve the objectives of the
Research Program, Wyeth will specifically use reasonably diligent efforts:
(a) to advance the pharmacological assessment
of compounds identified by OSI in order to select those worthy of further
investigation;
(b) to determine the chemical structure of the
selected compounds and to make related compounds to determine the relationship
between structure and activity and to identify potential development candidates;
(c) to select development candidates;
(d) to assess safety and efficacy of the
selected development candidates in animals and in human patients under
conditions designed to yield date suitable for inclusion in approval
applications to be submitted to the U.S. Food and Drug Administration; and
(e) to develop manufacturing methods and
pharmaceutical formulations for those selected candidates.
5. Treatment of Confidential Information.
5.1. Confidentiality.
5.1.1. Wyeth and OSI each recognize that the
other's Confidential Information constitutes highly valuable proprietary,
confidential information. Wyeth and OSI each agree that during the term of this
Agreement and for five (5) years thereafter, they will keep confidential all
Confidential Information that is disclosed to them or to any of their Affiliates
pursuant to this Agreement. Neither Wyeth nor OSI nor any of their Affiliates
shall use such Confidential Information except as expressly permitted in this
Agreement.
5.1.2. Wyeth and OSI acknowledge that the Wyeth and
OSI Confidential Information is highly valuable, proprietary, confidential
information, and agree that any disclosure of Confidential Information to any
officer, employee or agent of the other or of any of its Affiliates shall be
made only if, and to the extent, necessary to carry out its
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responsibilities under this Agreement and shall be limited to the maximum extent
possible consistent with such responsibilities. Each party agrees not to
disclose the other's Confidential Information to any third party under any
circumstance without written permission. Each party shall take such action, and
shall cause its Affiliates to take such action, to preserve the confidentiality
of the other's Confidential Information as it would customarily take to preserve
the confidentiality of its own confidential information. Each party, upon the
other's request, will return all the Confidential Information disclosed to it
pursuant to this Agreement, including all copies and extracts of documents
within sixty (60) days of the request after the termination of this Agreement.
5.1.3. OSI represents that all of its employees
participating in the Research Program who shall have access to Wyeth
Confidential Information are bound by agreements to maintain such information in
confidence. Consultants will be similarly bound.
5.2. Publication. Except as required to pursue patent
protection, the parties agree not to publish the results obtained in the course
of the Research Program unless mutually agreed, in which case the results may be
submitted for publication following scientific review by the Research Committee
and subsequent approval by OSI's and Wyeth's managements.
5.3. Disclosure of Inventions. Each party shall promptly
inform the other about all inventions that concern the Targets which are
conceived, made or developed in the course of carrying out the Research Program
by employees of, or consultants to, either of them solely, or jointly with
employees of, or consultants to, the other. This Agreement shall not be
construed to obligate either party to disclose to the other any invention which
does not concern the Targets.
5.4. Restrictions on Transferring Materials. Wyeth and
OSI recognize that the biological, biochemical and chemical compounds and
materials which are part of OSI Technology or Wyeth Technology represent
valuable commercial assets. Therefore, throughout the Contract Period and for
five (5) years thereafter, OSI and Wyeth each agree not to transfer to any third
party any such compound or material which constitutes Technology owned solely by
the other party. Additionally, throughout the Contract Period and for six (6)
months thereafter, OSI and Wyeth each agree not to transfer to any third party
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any such compound or material which constitutes Technology owned solely by it
unless prior consent for any such transfer is obtained from the other, which
consent shall not be unreasonably withheld, and unless such third party agrees
as a condition of any such transfer not to transfer the material further and to
use the material only for research purposes not directed toward the development
of Human Therapeutic Products.
6. Intellectual Property Rights.
6.1. Ownership. All OSI Technology and OSI Patent Rights
shall be owned solely by OSI regardless of whether such Technology or Patent
Rights are developed, conceived, discovered, or invented by employees of, or
consultants to, OSI solely or jointly with employees or, or consultants to,
Wyeth. All Wyeth Technology and Wyeth Patent Rights shall be owned solely by
Wyeth regardless of whether such Technology or Patent Rights are developed,
conceived, discovered, or invented by employees of, or consultants to, Wyeth
solely or jointly with employees of, or consultants to, OSI.
6.2. Filing, Prosecution and Maintenance of Patent Rights.
OSI shall have the exclusive right, at its expense and in its sole discretion to
file, prosecute, defend, enforce, and maintain OSI Patent Rights. Wyeth shall
have the exclusive right, at its expense and in its sole discretion to file,
prosecute, defend, enforce and maintain Wyeth Patent Rights.
6.3. Consultation Concerning Patent Rights. OSI and Wyeth
shall each provide to the other copies of all patent applications within OSI
Patent Rights or Wyeth Patent Rights, respectively, which relate to the Targets
prior to filing such applications for the purpose of obtaining substantive
comments of the other's patent counsel. Each party shall provide to the other
copies of all documents relating to prosecution of such patent applications in a
timely manner. Each party shall provide to the other every six (6) months a
reporting detailing the status of all such patent applications.
7. Acquisition of Rights from Third Parties. During the Contract
Period, OSI and Wyeth shall promptly notify each other in writing of any and all
opportunities to acquire in any manner from third parties, technology or patents
which may be useful in, or may relate to, the Research Program. OSI and Wyeth
shall decide if such rights shall be acquired and, if so, whether by OSI or
Wyeth. If acquired, such rights shall become OSI Technology or Wyeth
Technology, whichever is appropriate.
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8. Option to Receive Exclusive Licenses: Other Agreements.
8.3.1. OSI hereby grants to Wyeth an exclusive option to
obtain exclusive licenses on a Target by Target basis under the terms and
conditions set forth in the domestic and international License Agreements
appended hereto as Exhibits 2 and 3, respectively, with respect to any product
or products which may derive from the Collaborative Research Program in a Target
area. Wyeth may exercise its option to obtain an exclusive license at any time
during the term of this Agreement as soon as a potential Human Therapeutic
Product in a Target area is identified through the Collaborative Research
Program and upon the giving of written notice to OSI of its exercise of the
option provided by this section 8. It is further provided that Wyeth shall have
the right to identify a licensable Human Therapeutic Product in a specific
Target area for a period of up to one (1) year after the expiration of the
Collaborative Research Agreement.
8.3.2. Wyeth agrees that it will not develop, manufacture,
use or sell any compound identified as a potential Human Therapeutic Product
through the Collaborative Research Program other than pursuant to the terms and
conditions of the License Agreements appended hereto.
8.3.3. Other than the License Agreements appended hereto as
Exhibits 2 and 3, this Agreement is the sole agreement with respect to the
subject matter hereof.
9. Term, Extension, Termination and Disengagement.
9.1. Term. Unless sooner terminated or extended, this
Agreement shall expire on September 30, 1995, subject to the early termination
provisions in Section 9.5.
9.2. Extension. Wyeth, at least four months prior to the
end of the term, shall notify OSI in writing if it desires to extend the
Sponsored Research Program. If OSI is willing to extend the Sponsored Research
Program on mutually acceptable terms, OSI must so notify Wyeth within forty-five
(45) days after receipt of Wyeth's notice. Wyeth and OSI shall thereafter
promptly negotiate in good faith terms of any extension to this Agreement.
9.3. Events of Termination. The following events shall
constitute events of termination ("Events of Termination"):
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(a) any representation or warranty by OSI or Wyeth, or
any of its officers, under or in connection with this Agreement shall prove to
have been incorrect in any material respect when made;
(b) OSI or Wyeth shall fail in any material respect to
perform or observe any term, convent or understanding contained in this
Agreement or in any of the other documents or instruments delivered pursuant to,
or concurrently with, this Agreement, and any such failure shall remain
unremedied for thirty (30) days after written notice to the failing party.
9.4. Termination.
9.4.1. Upon the occurrence of any Event of
Termination, the party not responsible may, by notice to the other party,
terminate this Agreement.
9.4.2. If Wyeth terminates this Agreement pursuant
to Section 9.4.1, the License Agreements shall continue according to their
terms. If OSI terminates this Agreement pursuant to Section 9.4.1, the License
Agreements shall also terminate.
9.5. Termination by Wyeth. After this Agreement has been
in effect for a period of twenty (20) months, Wyeth may terminate this
Agreement, with or without cause, by giving OSI four (4) months notice at any
time after the expiration of said 20 month period. If Wyeth terminates this
Agreement pursuant to this section, it will make the Funding Payments which
would otherwise have been due for such four-month period and will retain all
rights set forth in any License Agreements then in effect subject to the
requirements of those Agreements.
10. Representations and Warranties. OSI and Wyeth each represents
and warrants as follows:
10.1. It is a corporation duly organized, validly existing
and in good standing under the laws of the State of Delaware and of New York,
respectively, and is qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which the conduct of its business or
the ownership of its properties requires such qualification and has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.
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10.2. The execution, delivery and performance by it of this
Agreement have been duly authorized by all necessary corporate action and do not
and will not (a) require any consent or approval of its stockholders, (b)
violate any provision of any law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter or by-laws or (c) result in
a breach of or constitute a default under any material agreement, mortgage,
lease, license, permit or other instrument or obligation to which it is a party
or by which it or its properties may be bound or affected.
10.3. This Agreement is a legal, valid and binding
obligation of it and is enforceable against it in accordance with its terms and
conditions, except as such enforceability may be limited by applicable
bankruptcy, insolvency, moratorium, reorganization or similar laws, from time to
time in effect, affecting creditor's rights generally.
10.4. It is not under any obligation to any Person,
contractual or otherwise, that is conflicting or inconsistent in any respect
with the terms of this Agreement or that would impede the diligent and complete
fulfillment of its obligations.
10.5. It has good and marketable title to or valid leases
or licenses for, all of its properties, rights and assets necessary for the
fulfillment of its responsibilities and the Research Program, subject to no
claim of any third party other than the relevant lessors or licensors.
11. Notices. All notices shall be mailed via certified mail,
return receipt requested, or courier, addressed as follows, or to such other
address as may be designated from time to time:
If to Wyeth: To Wyeth at its address as set forth at the
beginning of this Agreement
Attention: Executive Vice President,
Wyeth-Ayerst Research
with copy to: Office of the General
Counsel
If to OSI: To OSI at its address as set forth at the
beginning of this Agreement
Attention: President
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Notices shall be deemed given as of the date of receipt.
12. Governing Law. This Agreement shall be construed in
accordance with the laws of the State of New York.
13. Miscellaneous.
13.1. Binding Effect. This Agreement shall be binding upon
and inure to the benefit of the parties and their respective legal
representatives, successors and permitted assigns.
13.2. Headings. Paragraph headings are inserted for
convenience of reference only and do not form a part of this Agreement.
13.3. Counterparts. This Agreement may be executed
simultaneously in two or more counterparts, each of which shall be deemed an
original.
13.4. Amendment; Waiver; etc. This Agreement may be
amended, modified, superseded or canceled, and any of the terms may be waived,
only by a written instrument executed by each party or, in the case of waiver,
by the party or parties waiving compliance. The delay or failure of any part at
any time or times to require performance of any provision shall in no manner
affect its rights at a later time to enforce the same.
13.5. No Third Party Beneficiaries. No Person not a party
to this Agreement, including any employee of any party to this Agreement, shall
have or acquire any rights by reason of this Agreement. Nothing contained in
this Agreement shall be deemed to constitute the parties partners with each
other or any Person.
13.6. Assignment and Successors. This Agreement may not be
assigned by either party, in whole or in part, except to an Affiliate, to a
purchaser of all or substantially all of its assets or to any successor
corporation resulting from any merger or consolidation with or into such
corporation.
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IN WITNESS WHEREOF, the parties have caused this Agreement to
be executed by their duly authorized representatives.
AMERICAN HOME PRODUCTS CORPORATION
By:_________________________________
Title:______________________________
ONCOGENE SCIENCE, INC.
By:_________________________________
Title:______________________________
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EXHIBIT 1
ANNUAL SPONSORED RESEARCH PLAN
FOR COMMITMENT YEARS 1 AND 2 OF THE
WYETH-AYERST/ONCOGENE SCIENCE
COLLABORATIVE RESEARCH AGREEMENT
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1. Executive Summary
Oncogene Science has developed a proprietary gene transcription-based technology
to identify new drug leads. A summary reviewing the advantages of gene
transcription as an approach to drug discovery is attached in Appendix 1. A
collaboration with Wyeth-Ayerst Research is proposed to exploit this technology
in order to develop drugs in four therapeutic areas: non-insulin dependent
diabetes, immunomodulation, asthma, and osteoporosis. The immediate goal is
to identify small molecular weight compounds which specifically modulate the
transcription of four target genes *** thereby either increasing or decreasing
the concentration of the corresponding protein product. ***.
***
***
*** These portions deleted pursuant to a request for confidential treatment.
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2. Program Overview
Oncogene Science has developed a unique drug discovery technology specifically
designed to identify compounds which affect the transcription of target genes.
Once a particular gene has been chosen as a target, the next step of the process
is to clone the regions of DNA which regulate expression of that gene. These
sequences are then fused to a highly sensitive reporter gene (the firefly
luciferase gene) which generates a readily measurable signal in response to
changes in transcription of the target gene. This genetically engineered DNA
construct is then introduced into an appropriate cell type and stable lines
isolated. Such cell lines will generate a signal which reflects a change in gene
expression when an appropriate compound is added to the tissue culture media.
Lead identification is based upon very highthroughput drug screening, ie.,
screening up to 100,000 compounds or fermentation broths against each target in
a single year. To achieve this, a fully automated screening system has been
developed using state-of-the-art robotics developed at Oncogene Science.
Complete automation not only allows the primary screen to be cost effective, but
has proved essential to obtain highly quantitative and reproducible data from a
transcription based screen of this type. Each robotic system can analyze several
thousand samples per week against multiple target genes.
By using multiple targets in the primary screen, activity, cytotoxicity, and
initial gene specificity can be evaluated rapidly. ***. Compounds which are
active in the primary screen are immediately retested to establish an
EC(50)/cytotoxicity index. Automated on-line data reduction and statistical
analysis allows rapid quantitative determination to identify the initial lead
compounds. Complete data sets and lists of lead compounds can be provided in a
format compatible with Wyeth Ayerst's existing data analysis system. ***.
Appropriate tertiary assays and animal models can then be employed for the later
stages of lead development, and typically would be conducted at Wyeth-Ayerst.
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Appendix A
Payment Schedule
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Appendix B
Development/Screening Collaborative Program
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EXHIBIT 2
LICENSE AGREEMENT
This LICENSE AGREEMENT is entered into as of ___________, 1991 (the
"Effective Date") by and between AMERICAN HOME PRODUCTS CORPORATION, a
corporation of the State of Delaware, U.S.A., having its principal place of
business at 685 Third Avenue, New York, New York 10017, U.S.A., as represented
by its agent, Wyeth-Ayerst Laboratories Division (hereinafter collectively
referred to as "Wyeth") and ONCOGENE SCIENCE, INC. (hereinafter referred to as
"OSI"), a corporation of the State of Delaware, having its principal place of
business at 106 Charles Lindbergh Blvd., Uniondale, New York 11553, U.S.A.
In consideration of the mutual covenants and promises set forth in this
Agreement, the parties agree as follows:
1. Definitions.
The capitalized terms used in this Agreement shall have the meanings
specified for such terms in this Section 1 and in Section 1 of the Collaborative
Research Agreement to which this License Agreement is appended.
1.1 "Collaborative Research Agreement" means the Collaborative Research
Agreement between Wyeth and OSI effective ___________, 1991.
1.2 "Net Sales" means the gross sales by Wyeth or any sublicensee of
Wyeth for arm's-length sales to a third party or parties of Licensed Human
Therapeutic Products, less transportation, normal returns and allowance
(actually paid or allowed by Wyeth), customary discounts (whether cash or trade)
and sales or other taxes based on the sales prices whether
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or not absorbed by Wyeth, but not including taxes assessed against income
derived from such sales.
1.3 "Licensed Human Therapeutic Product" means a Human Therapeutic
Product that employs Wyeth Patents Rights, OSI Patent Rights, Wyeth Technology
or OSI Technology in its manufacture, use or sale.
1.4 "Territory" means the United States of America, its territories
and possessions and the Commonwealth of Puerto Rico.
2. Grant of Licenses.
2.1 License Granted to Wyeth under OSI Patent Rights.
OSI grants to Wyeth the exclusive license, including the right
to grant sublicenses, to develop, make, use and sell Human Therapeutic Products
in the Territory under all OSI's right, title and interest in OSI Patent Rights.
2.2 License Granted to Wyeth under OSI Technology.
OSI grants to Wyeth the exclusive license, including the right
to grant sublicenses, to develop, make, use and sell Human Therapeutic Products
in the Territory under all OSI's right, title and interest in OSI Technology.
2.3 Term of License Grants.
2.3.1 The term of the grant set forth in Section 2.1 shall
commence on the Effective Date and shall terminate on the date of the last to
expire of OSI Patent Rights.
2.3.2 The term of the grant set forth in Section 2.2 shall
commence on the Effective Date and shall run perpetually.
2.3.3 Wyeth shall have a royalty-free license to manufacture,
use and sell
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each Licensed Human Therapeutic Product in the Territory after the expiration of
Wyeth's last obligation to pay royalties on Net Sales of such Licensed Human
Therapeutic Product.
2.4 Wyeth Obligations.
2.4.1 Wyeth shall use reasonably diligent efforts to
commercially develop Licensed Human Therapeutic Products. This requirement shall
be deemed satisfied with respect to any specific Target area if Wyeth is
developing any Human Therapeutic Product in that Target area. Such development
will be shown by semi-annual progress reports which demonstrate that the Human
Therapeutic Product remains an active candidate for filing in an Investigational
New Drug Application with the U.S. Food and Drug Administration. Wyeth shall
have an exclusive license to all Human Therapeutic Products arising from the
Collaborative Research Program in a Target Area so long as it satisfies its
development obligation with respect to any specific Target area as provided for
in this Section 2.4.1.
2.4.2 In the event that, in the course of its development of a
Human Therapeutic Product as provided for in Section 2.5.1, it becomes apparent,
in Wyeth's determination, that a Product or Products will not be commercially
viable, the parties agree to the following disposition of such Product or
Products:
a) if the determination arises during or after the term of
the Collaborative Research Agreement, and the Product or Products are not the
sole development candidates in a specific Target area, the Product or Products
shall remain exclusively licensed to Wyeth;
b) if the determination arises after expiration of the
Collaborative Research Agreement and if the Products are the sole development
candidate or candidates in a specific Target area, OSI shall have the option to
an exclusive license thereto, including the right to
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grant sublicenses, under Wyeth Patent Rights and Wyeth Technology on terms to be
negotiated mutually by the parties.
2.5 Technical Assistance.
OSI shall provide to Wyeth or any sublicensee of Wyeth, at
Wyeth's request and expense, any assistance reasonably necessary to enable Wyeth
or such sublicensee to manufacture, use or sell each Licensed Human Therapeutic
Product and to enjoy fully all the rights granted to Wyeth pursuant to this
Agreement.
3. Royalties, Payments of Royalties, Accounting for Royalties Records.
3.1 Patent and Tgchnology Rights.
Wyeth shall pay OSI a royalty based on the Net Sales of each
Licensed Human Therapeutic Product, the manufacture, use or sale of which would
infringe a Valid Claim within OSI Patent Rights or Wyeth Patent Rights if such
manufacture, use or sale were by an unlicensed third party or which employs OSI
Technology or Wyeth Technology. Such royalty shall be paid from the date of
first commercial sale of each such Licensed Human Therapeutic Product until the
expiration of the last applicable patent to expire or ten (10) years from the
date of such first commercial sale, whichever is later.
3.2 Royalty Rates - Patent Rights and Technology.
Wyeth shall pay OSI a royalty of *** percent *** of Net Sales
of each Human Therapeutic Product licensed under Section 2.1 or 2.2. Only one
royalty will be due on Net Sales of any such Human Therapeutic Product.
3.3 Payment Dates.
Royalties shall be paid by Wyeth on Net Sales within sixty (60)
days after the
*** These portions deleted pursuant to a request for confidential treatment.
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end of each calendar quarter in which such Net Sales are made. Such payments
shall be accompanied by a statement showing the Net Sales of each Licensed Human
Therapeutic Product by Wyeth or any sublicensee of Wyeth and a calculation of
the amount of royalty due.
3.4 Accounting.
No royalties on Net Sales shall be payable on sales
transactions between or among Wyeth and its Affiliates; the final vendee sale to
a third party alone shall be used for the purpose of determining the royalty
payments due hereunder. The Licensed Human Therapeutic Product subject to
royalty payment shall be deemed sold when invoiced, or if not invoiced, when the
same shall be shipped or delivered to the third party. All taxes, assessments
and fees of any nature levied or incurred on account of any payments accruing
under this Agreement, by national, state or local governments, will be assumed
and paid by Wyeth except taxes levied thereon as income to OSI and if such taxes
are required to be withheld by Wyeth, they will be deducted from such payments
due to OSI and will be paid by Wyeth for the account of OSI, and a receipt
therefor secured and sent to OSI.
3.5 Records.
Wyeth shall keep for three (3) years from the date of each
payment of royalties complete and accurate records of sales by Wyeth of each
Licensed Human Therapeutic Product in sufficient detail to allow the accruing
royalties to be determined accurately. OSI shall have the right for a period of
three (3) years after receiving any report or statement with respect to
royalties due and payable to appoint at its expense an independent certified
public accountant reasonably acceptable to Wyeth to inspect the relevant records
of Wyeth to verify
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such report or statement. Wyeth shall make its records available for inspection
by such independent certified public accountant during regular business hours at
such place or places where such records are customarily kept, upon reasonable
notice from OSI, to the extent reasonably necessary to verify the accuracy of
the reports and payments. Such inspection right shall not be exercised more than
once in any calendar year nor more than once with respect to sales in any given
period. OSI agrees to hold in strict confidence all information concerning
royalty payments and reports, and all information learned in the course of any
audit or inspection, except to the extent it is necessary for OSI to reveal such
information in order to enforce its rights under this Agreement or if disclosure
is required by law. The failure of OSI to request verification of any report or
statement during said three-year period shall be considered acceptance of the
accuracy of such report, and Wyeth shall have no obligation to maintain records
pertaining to such report or statement beyond said three-year period. The
results of the inspection shall be binding on both parties.
4. Legal Action.
4.1.1 Actual or Threatened Disclosure or Infringement of Wyeth Patent
Rights or Technology
When information comes to the attention of Wyeth to the effect
that any Wyeth Patent Rights or Technology relating specifically to a Licensed
Human Therapeutic Product have been, or are threatened to be, unlawfully
disclosed or that any of the exclusive rights granted by this Agreement has been
or is threatened to be unlawfully infringed, Wyeth shall have the right at its
expense to take such action as it may deem necessary to prosecute or prevent
such unlawful disclosure or infringement, including the right to bring or defend
any
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suit, action or proceeding involving any such disclosure or infringement. Wyeth
shall notify OSI promptly of the receipt of any such information and of the
commencement of any such suit, action or proceeding. If Wyeth determines that it
is necessary or desirable for OSI to join any such suit, action or proceeding,
OSI shall execute all papers and perform such other acts as may be reasonably
required to permit Wyeth to act in OSI's name. In the event that Wyeth brings a
suit, it shall have the right first to reimburse itself out of any sums
recovered in such suit or insist settlement for all reasonable costs and
expenses of every kind and character, including reasonable attorney's fees,
involved in the prosecution of any suit, and *** percent *** of any funds that
shall remain from said recovery shall be distributed to OSI and the balance of
such funds shall be retained by Wyeth. If Wyeth does not, within one hundred
twenty (120) days after giving notice to OSI of the above-described information,
notify OSI of Wyeth's intent to bring suit against any infringer, OSI shall have
the right to bring suit for such alleged infringement, but it shall not be
obligated to so do, and may join Wyeth as party plaintiff, if appropriate, in
which event OSI shall hold Wyeth free, clear and harmless from any and all costs
and expenses of such litigation, including attorney's fees, and any sums
recovered in any such suit or in its settlement shall belong to OSI. However,
*** percent *** of any such sums received by OSI, after deduction of the costs
and expenses of litigation, including attorney's fees paid, shall be paid to
Wyeth. Each party shall always have the right to be represented by counsel of
its own selection and at its own expense in any suit instituted by the other for
infringement, under the terms of this Section 4.1.1. If Wyeth lacks standing to
bring any such suit, action or proceeding, then OSI shall do so at the request
of Wyeth and at Wyeth's expense.
*** These portions deleted pursuant to a request for confidential treatment.
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4.1.2 Actual or Threatened Disclosure or Infringement of OSI Patent
Rights or Technology
When information comes to the attention of OSI to the effect
that any OSI Patent Rights or Technology relating specifically to a Licensed
Human Therapeutic Product have been, or are threatened to be, unlawfully
disclosed or that any of the exclusive rights granted by this Agreement has
been, or is threatened to be, unlawfully infringed, OSI shall have the right at
its expense to take such action as it may deem necessary to prosecute or prevent
such unlawful disclosure or infringement, including the right to bring or defend
any suit, action or proceeding involving any such disclosure or infringement.
OSI shall notify Wyeth promptly of the receipt of any such information and of
the commencement of any such suit, action or proceeding. If Wyeth determines
that it is necessary or desirable for Wyeth to join any such suit, action or
proceeding, Wyeth shall execute all papers and perform such other acts as may be
reasonably required to permit OSI to act in Wyeth's name. In the event that OSI
brings a suit, it shall have the right first to reimburse itself out of any sums
recovered in such suit or in its settlement for all reasonable costs and
expenses of every kind and character, including reasonable attorney's fees,
involved in the prosection of any suit, and *** percent *** of any funds that
shall remain from said recovery shall be distributed to Wyeth and the balance of
such funds shall be retained by OSI. If OSI does not, within one hundred twenty
(120) days after giving notice to Wyeth of the above-described information,
notify Wyeth of OSI's intention to bring suit against any infringer, Wyeth shall
have the right to bring suit for such alleged infringement, but it shall not be
obligated to do so, and may join OSI as party plaintiff, if appropriate, in
which event Wyeth shall hold OSI
*** These portions deleted pursuant to a request for confidential treatment.
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free, clear and harmless from any and all costs and expenses of such litigation,
including attorney's fees, and any sums recovered in any such suit or in its
settlement shall belong to Wyeth. However, *** percent *** of any such sums
received by Wyeth, after deduction of the costs and expenses of litigation,
including attorney's fees paid, shall be paid to OSI. Each party shall always
have the right to be presented by counsel of its own selection and at its own
expense in any suit instituted by the other for infringement, under the terms of
this Section 4.1.2. If OSI lacks standing to bring any such suit, action or
proceeding, then Wyeth shall do so at the request of OSI and at OSI's expense.
4.2 Defense of Infringement Claims.
OSI will cooperate with Wyeth at Wyeth's expense in the defense
of any suit, action or proceeding against Wyeth or any sublicensee of Wyeth
alleging the infringement of the intellectual property rights of a third party
by reason of the use of Patent Rights or Technology in the manufacture, use or
sale of any Licensed Human Therapeutic Product. Wyeth shall give OSI prompt
written notice of the commencement of any such suit, action or proceeding or
claim of infringement and will furnish OSI a copy of each communication relating
to the alleged infringement. OSI shall give to Wyeth all authority (including
the right to exclusive control of the defense of any such suit, action or
proceeding and the exclusive right to compromise, litigate, settle or otherwise
dispose of any such suit, action or proceeding), information and assistance
necessary to defend or settle any such suit, action or proceeding. If the
parties agree that OSI should institute or join any suit, action or proceeding
pursuant to this Section 4.2, Wyeth may join OSI as a defendant if necessary or
desirable, and OSI at Wyeth's expense shall executive all documents and take all
other
*** These portions deleted pursuant to a request for confidential treatment.
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actions, including giving testimony, which may reasonably be required in
connection with the prosecution of such suit, action or proceeding.
4.3 Hold Harmless.
OSI agrees to defend, protect, indemnify and hold harmless
Wyeth and any sublicensee of Wyeth, from and against any loss or expense arising
from any proven claim of a third party that it has been granted rights by OSI
that Wyeth or any sublicensee of Wyeth in exercising the rights granted to Wyeth
by OSI pursuant to this Agreement, has infringed upon such rights granted to
such third party by OSI. Wyeth agrees to defend, protect, indemnify and hold
harmless OSI from and against any liability, claim, loss, cost or expense
arising from any claim for liability based upon Wyeth's manufacture, use or sale
of any Licensed Human Therapeutic Product.
4.4 Third Party License.
If the manufacture, use or sale by Wyeth of a Licensed Human
Therapeutic Product would, in the opinion of both Wyeth and OSI, infringe a
patent owned by a third party, Wyeth and OSI shall attempt to obtain a license
under such patent. If Wyeth obtains a license under such patent, (fifty) percent
(50%) of any payments made by Wyeth to such third party shall be deductible from
royalty payments due from Wyeth to OSI pursuant to this Agreement; provided,
however, that in no event shall royalties payable to OSI be reduced by more than
twenty-five percent (25%) as a result of all such deductions. All such
computations, payments, and adjustments shall be on a patent by patent basis. If
OSI is of the opinion that such manufacture, use or sale would not infringe such
patent owned by a third party, OSI may, at its election, bring suit against such
third party seeking a declaration
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that such patent is invalid or not infringed by Wyeth's manufacture, use or sale
of the Licensed Human Therapeutic Product involved, or may bring opposition,
nullity or other proceedings against such patent, as appropriate. If OSI is
successful in such suit, Wyeth shall continue to pay royalties in such country
as provided in Section 3. If OSI is unsuccessful in such suit, it shall join
Wyeth in an attempt to obtain a license under such patent, and fifty percent
(50%) of any payments made by Wyeth to such third party for such license shall
be deductible from royalty payments due from Wyeth to OSI as to that patent
pursuant to this Agreement.
5. Termination by Wyeth
Wyeth may terminate this Agreement at any time without cause by giving
OSI at least six (6) months notice prior to the termination date. Such
termination will not affect the rights and obligations of the parties accrued
prior to the termination, including the right of OSI to receive royalties on
subsequent sales of Licensed Human Therapeutic Products, and OSI shall be
entitled to an exclusive license under Wyeth Patent Rights and Wyeth Technology
in the Target area(s) on the same terms under which Wyeth is exclusively
licensed under OSI Patent Rights and OSI Technology as provided for in this
Agreement.
6. Representation and Warranty.
OSI and Wyeth represent and warrant to each other that they have the
right to grant to each other the licenses granted to them pursuant to this
Agreement, and that the licenses so granted do not conflict with or violate the
terms of any agreement between either of them and any third party.
7. Notices. All notices shall be mailed via certified mail, return
receipt requested, or
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courier, addressed as follows, or to such other address as may be designated
from time to time:
If to Wyeth: To Wyeth at its address as set forth at the beginning
of this Agreement
Attention: President,
Wyeth-Ayerst Laboratories
with copy to: Office of the General Counsel
If to OSI: To OSI at its address as set forth at the beginning of
this Agreement
Attention: President
Notices shall be deemed given as of the date of receipt.
8. Additional Terms.
The following terms of the Collaborative Research Agreement are
incorporated into this Agreement as if set forth verbatim:
(a) Sections 9.3 and 9.4;
(b) Sections 5.1 and 5.2;
(c) Sections 6.1 through 6.3, inclusive;
(d) Section 12; and
(e) Section 13.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
AMERICAN HOME PRODUCTS CORPORATION
By_____________________________
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Title____________________________
ONCOGENE SCIENCE, INC.
By_____________________________
Title___________________________
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EXHIBIT 3
LICENSE AGREEMENT
This LICENSE AGREEMENT is entered into as of ___________, 1991 (the
"Effective Date") by and between AMERICAN HOME PRODUCTS CORPORATION, a
corporation of the State of Delaware, U.S.A., having its principal place of
business at 685 Third Avenue, New York, New York 10017, U.S.A., as represented
by its agent, Wyeth-Ayerst Laboratories Division (hereinafter collectively
referred to as "Wyeth") and ONCOGENE SCIENCE, INC. (hereinafter referred to as
"OSI"), a corporation of the State of Delaware, having its principal place of
business at 106 Charles Lindbergh Blvd., Uniondale, New York 11553, U.S.A.
In consideration of the mutual covenants and promises set forth in this
Agreement, the parties agree as follows:
1. Definitions.
The capitalized terms used in this Agreement shall have the meanings
specified for such terms in this Section 1 and in Section 1 of the Collaborative
Research Agreement to which this License Agreement is appended.
1.1 "Collaborative Research Agreement" means the Collaborative Research
Agreement between Wyeth and OSI effective ___________, 1991.
1.2 "Net Sales" means the gross sales by Wyeth or any sublicensee of
Wyeth for arm's length sales to a third party or parties of Licensed Human
Therapeutic Products, less transportation, normal returns and allowance
(actually paid or allowed by Wyeth), customary discounts (whether cash or trade)
and sales or other taxes based on the sales prices whether
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or not absorbed by Wyeth, but not including taxes assessed against income
derived from such sales.
1.3 "Licensed Human Therapeutic Product" means a Human Therapeutic
Product that employs Wyeth Patent Rights, OSI Patent Rights, Wyeth Technology,
or OSI Technology in its manufacture, use or sale.
1.4 "Territory" means all countries of the world, except the United
States of America, its territories and possessions and the Commonwealth of
Puerto Rico.
2. Grant of Licenses.
2.1 License Granted to Wyeth under OSI Patent Rights.
OSI grants to Wyeth the exclusive license, including the right
to grant sublicenses, to develop, make, use and sell Human Therapeutic Products
in the Territory under all OSI's right, title and interest in OSI Patent Rights.
2.2 License Granted to Wyeth under OSI Technology.
OSI grants to Wyeth the exclusive license, including the right
to grant sublicenses, to develop, make, use and sell Human Therapeutic Products
in the Territory under all OSI's right, title and interest in OSI Technology.
2.3 Term of License Grants.
2.3.1 The term of the grant set forth in Section 2.1 shall
commence on the Effective Date and shall terminate on the date of the last to
expire of OSI Patent Rights.
2.3.2 The term of the grant set forth in Section 2.2 shall
commence on the Effective Date and shall run perpetually, except in those
countries of the Territory in which such term is limited by law.
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2.3.3 Wyeth shall have a royalty-free license to manufacture,
use and sell each Licensed Human Therapeutic Product in each country of the
Territory after the expiration of Wyeth's last obligation to pay royalties on
Net Sales of each such Licensed Human Therapeutic Product in each such country.
2.4 Wyeth Obligations.
2.4.1 Wyeth shall use reasonably diligent efforts to
commercially develop Licensed Human Therapeutic Products. This requirement shall
be deemed satisfied with respect to any specific Target area if Wyeth is
developing any Human Therapeutic Product in that Target area. Such development
will be shown by semi-annual progress reports which demonstrate that the Human
Therapeutic Product remains an active candidate for the filing of a foreign
equivalent of an Investigational New Drug Application. Wyeth shall have an
exclusive license to all Human Therapeutic Products arising from the
Collaborative Research Program in a Target Area so long as it satisfies its
development obligation with respect to any specific Target area as provided for
in this Section 2.4.1.
2.4.2 In the event that, in the course of its development of a
Human Therapeutic Product as provided for in Section 2.4.1, it becomes apparent,
in Wyeth's determination, that a Product or Products will not be commercially
viable, the parties agree to the following disposition of such Product or
Products:
a) if the determination arises during or after the term of
the Collaborative Research Agreement, and the Product or Products are not the
sole development candidates in a specific Target area, the Product or Products
shall remain exclusively licensed to Wyeth;
b) if the determination arises after expiration of the
Collaborative Research
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Agreement and if the Products are the sole development candidate or candidates
in a specific Target area, OSI shall have the option to an exclusive license
thereto, including the right to grant sublicenses, under Wyeth Patent Rights and
Wyeth Technology on terms to be negotiated mutually by the parties.
2.5 Technical Assistance.
OSI shall provide to Wyeth or any sublicensee or Direct
Licensee of Wyeth at Wyeth's request and expense, any assistance reasonably
necessary to enable Wyeth or such sublicensee or Direct Licensee to manufacture,
use or sell each Licensed Human Therapeutic Product and to enjoy fully all the
rights granted to Wyeth pursuant to this Agreement.
3. Royalties, Payments of Royalties, Accounting for Royalties, Records.
3.1 Patent and Technology Rights.
Wyeth shall pay OSI a royalty based on the Net Sales in each
country of each Licensed Human Therapeutic Product, the manufacture, use or sale
of which would infringe a Valid Claim within OSI Patent Rights or Wyeth Patent
Rights if such manufacture, use or sale were by an unlicensed third party or
which employs OSI Technology of Wyeth Technology. Such royalty shall be paid in
each country of the Territory from the date of first commercial sale of each
such Licensed Human Therapeutic Product in each such country until the
expiration of the last applicable patent to expire with respect to each such
country or ten (10) years from the date of such first commercial sale in each
such country, whichever is later.
3.2 Royalty Rates - Patent Rights and Technology.
Wyeth shall pay OSI a royalty of *** percent *** of Net Sales
of each
***These portions deleted pursuant to a request for confidential treatment.
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Human Therapeutic Product licensed under Section 2.1 or 2.2. Only one royalty
will be due on Net Sales of any such Human Therapeutic Product.
3.3 Direct Licensees.
Wyeth may, at any time, request from OSI and OSI agrees to
grant directly to any party ("Direct Licensee(s)") in any country of the
Territory exclusive license rights consistent with those granted to Wyeth
herein. Accordingly, upon receipt of Wyeth's request, OSI shall enter into and
sign a separate direct license agreement or agreements with the companies
designated by Wyeth in the request. All direct agreements shall be prepared by
Wyeth. In the event that the laws and regulations of the country(ies) require
modification of the royalty rate, duration and/or terms and conditions, the
direct licenses to Direct Licensees shall be so modified. In the absence or upon
the expiration of such laws and regulations, the terms and conditions of any
such direct license shall not be less favorable to OSI than those contained in
this Agreement. In those countries in which the validity of such direct license
requires prior governmental approval or registration, such direct license shall
not be binding or have any force or effect until the required governmental
approval or registration has been granted.
3.4 Payment Dates.
Royalties shall be paid by Wyeth on Net Sales within sixty (60)
days after the end of each calendar quarter in which such Net Sales are made.
Such payments shall be accompanied by a statement showing the Net Sales of each
Licensed Human Therapeutic Product by Wyeth or any sublicensee of Wyeth in each
country of the Territory and a calculation of the amount of royalty due.
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3.5 Accounting.
(a) The royalties provided for herein shall accrue and be
payable in the national currency of the country where the sale on which payment
is based was made, provided that:
(i) if law or regulation permits the conversion of such
currency into U.S. currency, the same shall be converted into the equivalent
value in U.S. currency at the applicable rate of exchange existing at the time
of conversion and paid in U.S. currency to OSI at the place of payment;
(ii) if the conversion into and/or remittance of U.S.
currency is subject to administrative authorization, appropriate action will be
taken with the competent authorities to apply diligent efforts to obtain such
authorization so as to pay the royalty in U.S. currency within the time
stipulated for payment of the royalty;
(iii) if by law, regulations or fiscal policy of a
country conversion into or transfer of U.S. currency is restricted or forbidden,
notice thereof in writing will be given to OSI and payment of the royalty shall
be made through such lawful means or method as OSI may designate and at OSI's
expense. Failing the designation by OSI of such lawful means or method as
aforesaid within a period of sixty (60) days after the aforementioned notice is
given to OSI, the payment of such royalty by Wyeth shall be made by the deposit
thereof in local currency to the credit of OSI in a recognized banking
institution designated by OSI or if none be designated by it within the period
of sixty (60) days as aforesaid then in a recognized banking institution
notified to OSI; and
(b) Except for those instances provided for by subsections
(i), (ii) and (iii)
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above, Wyeth shall guarantee the determination and payment of royalties on all
sales made by Wyeth, and its sublicensees and Direct Licensees.
(c) All taxes, assessments and fees of any nature levied or
incurred on account of any payments accruing under this Agreement, by national,
state or local governments, will be assumed and paid by Wyeth except taxes
levied thereon as income to OSI and if such taxes are required to be withheld by
Wyeth, they will be deducted from such payments due to OSI and will be paid by
Wyeth for the account of OSI, and a receipt therefor secured and sent to OSI.
3.6 Records.
Wyeth shall keep for three (3) years from the date of each
payment of royalties complete and accurate records of sales by Wyeth of each
Licensed Human Therapeutic Product in sufficient detail to allow the accruing
royalties to be determined accurately. OSI shall have the right for a period of
three (3) years after receiving any report or statement with respect to
royalties due and payable to appoint at its expense an independent certified
public accountant reasonably acceptable to Wyeth to inspect the relevant records
of Wyeth to verify such report or statement. Wyeth shall make its records
available for inspection by such independent certified public accountant during
regular business hours at such place or places where such records are
customarily kept, upon reasonable notice from OSI, to the extent reasonably
necessary to verify the accuracy of the reports and payments. Such inspection
right shall not be exercised more than once in any calendar year nor more than
once with respect to sales in any given period. OSI agrees to hold in strict
confidence all information concerning royalty payments and reports, and all
information learned in the course of any
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audit or inspection, except to the extent it is necessary for OSI to reveal such
information in order to enforce its rights under this Agreement or if disclosure
is required by law. The failure of OSI to request verification of any report or
statement during said three-year period shall be considered acceptance of the
accuracy of such report, and Wyeth shall have no obligation to maintain records
pertaining to such report or statement beyond said three-year period. The
results of the inspection shall be binding on both parties.
4. Legal Action.
4.1.1 Actual or Threatened Disclosure or Infringement of Wyeth Patent
Rights or Technology
When information comes to the attention of Wyeth to the effect
that any Wyeth Patent Rights or Technology relating specifically to a Licensed
Human Therapeutic Product have been, or are threatened to be, unlawfully
disclosed or that any of the exclusive rights granted by this Agreement has been
or is threatened to be unlawfully infringed, Wyeth shall have the right at its
expense to take such action as it may deem necessary to prosecute or prevent
such unlawful disclosure or infringement, including the right to bring or defend
any suit, action or proceeding involving any such disclosure or infringement.
Wyeth shall notify OSI promptly of the receipt of any such information and of
the commencement of any such suit, action or proceeding. If Wyeth determines
that it is necessary or desirable for OSI to join any such suit, action or
proceeding, OSI shall execute all papers and perform such other acts as may be
reasonably required to permit Wyeth to act in OSI's name. In the event that
Wyeth brings a suit, it shall have the right first to reimburse itself out of
any sums recovered in such suit or insist settlement for all reasonable costs
and expenses of every kind and
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character, including reasonable attorney's fees, involved in the prosecution of
any suit, and *** percent *** of any funds that shall remain from said
recovery shall be distributed to OSI and the balance of such funds shall be
retained by Wyeth. If Wyeth does not, within one hundred twenty (120) days after
giving notice to OSI of the above-described information, notify OSI of Wyeth's
intent to bring suit against any infringer, OSI shall have the right to bring
suit for such alleged infringement, but it shall not be obligated to so do, and
may join Wyeth as party plaintiff, if appropriate, in which event OSI shall hold
Wyeth free, clear and harmless from any and all costs and expenses of such
litigation, including attorney's fees, and any sums recovered in any such suit
or in its settlement shall belong to OSI. However, *** percent *** of any such
sums received by OSI, after deduction of the costs and expenses of litigation,
including attorney's fees paid, shall be paid to Wyeth. Each party shall always
have the right to be represented by counsel of its own selection and at its own
expense in any suit instituted by the other for infringement, under the terms of
this Section 4.1.1. If Wyeth lacks standing to bring any such suit, action or
proceeding, then OSI shall do so at the request of Wyeth and at Wyeth's expense.
4.1.2 Actual or Threatened Disclosure or Infringement of OSI Patent
Rights or Technology
When information comes to the attention of OSI to the effect
that any OSI Patent Rights or Technology relating specifically to a Licensed
Human Therapeutic Product have been, or are threatened to be, unlawfully
disclosed or that any of the exclusive rights granted by this Agreement has
been, or is threatened to be, unlawfully infringed, OSI shall have the right at
its expense to take such action as it may deem necessary to prosecute or
*** These portions deleted pursuant to a request for confidential treatment.
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prevent such unlawful disclosure or infringement, including the right to bring
or defend any suit, action or proceeding involving any such disclosure or,
infringement. OSI shall notify Wyeth promptly of the receipt of any such
information and of the commencement of any such suit, action or proceeding. If
Wyeth determines that it is necessary or desirable for Wyeth to join any such
suit, action or proceeding, Wyeth shall execute all papers and perform such
other acts as may be reasonably required to permit OSI to act in Wyeth's name.
In the event that OSI brings a suit, it shall have the right first to reimburse
itself out of any sums recovered in such suit or in its settlement for all
reasonable costs and expenses of every kind and character, including reasonable
attorneys fees, involved in the prosection of any suit, and *** percent *** of
any funds that shall remain from said recovery shall be distributed to Wyeth and
the balance of such funds shall be retained by OSI. If OSI does not, within one
hundred twenty (120) days after giving notice to Wyeth of the above-described
information, notify Wyeth of OSI's intention to bring suit against any
infringer, Wyeth shall have the right to bring suit for such alleged
infringement, but it shall not be obligated to do so, and may join OSI as party
plaintiff, if appropriate, in which event Wyeth shall hold OSI free, clear and
harmless from any and all costs and expenses of such litigation, including
attorney's fees, and any sums recovered in any such suit or in its settlement
shall belong to Wyeth. However, *** percent *** of any such sums received by
Wyeth, after deduction of the costs and expenses of litigation, including
attorney's fees paid, shall be paid to OSI. Each party shall always have the
right to be presented by counsel of its own selection and at its own expense in
any suit instituted by the other for infringement, under the terms of this
Section 4.1.2. If OSI lacks standing to bring any such suit, action or
proceeding, then Wyeth
*** These portions deleted pursuant to a request for confidential treatment.
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shall do so at the request of OSI and at OSI's expense.
4.2 Defense of Infringement Claims.
OSI will cooperate with Wyeth at Wyeth's expense in the defense
of any suit, action or proceeding against Wyeth or any sublicensee of Wyeth
alleging the infringement of the intellectual property rights of a third party
by reason of the use of Patent Rights or Technology in the manufacture, use or
sale of any Licensed Human Therapeutic Product. Wyeth shall give OSI prompt
written notice of the commencement of any such suit, action or proceeding or
claim of infringement and will furnish OSI a copy of each communication relating
to the alleged infringement. OSI shall give to Wyeth all authority (including
the right to exclusive control of the defense of any such suit, action or
proceeding and the exclusive right to compromise, litigate, settle or otherwise
dispose of any such suit, action or proceeding), information and assistance
necessary to defend or settle any such suit, action or proceeding pursuant to
this Section 4.2. Wyeth may join OSI as a defendant if necessary or desirable,
and OSI at Wyeth's expense shall executive all documents and take all other
actions, including giving testimony, which may reasonably be required in
connection with the prosecution of such suit, action or proceeding.
4.3 Hold Harmless.
OSI agrees to defend, protect, indemnify and hold harmless
Wyeth and any sublicensee of Wyeth, from and against any loss or expense arising
from any proven claim of a third party that it has been granted rights by OSI
that Wyeth or any sublicensee of Wyeth in exercising the rights granted to Wyeth
by OSI pursuant to this Agreement, has infringed upon such rights granted to
such third party by OSI. Wyeth agrees to defend, protect,
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indemnify and hold harmless OSI from and against any liability, claim, loss,
cost or expense arising from any claim for liability based upon Wyeth's
manufacture, use or sale of any Licensed Human Therapeutic Product.
4.4 Third Party License.
If the manufacture, use or sale by Wyeth of a Licensed Human
Therapeutic Product in any country would, in the opinion of both Wyeth and OSI,
infringe a patent owned by a third party, Wyeth and OSI shall attempt to obtain
a license under such patent. If Wyeth obtains a license under such patent, fifty
percent (50%) of any payments made by Wyeth to such third party shall be
deductible from royalty payments due from Wyeth to OSI pursuant to this
Agreement; provided, however, that in no event shall royalties payable to OSI be
reduced by more than twenty-five percent (25%) as a result of all such
deductions. All such computations, payments, and adjustments shall be on a
country by country and patent by patent basis. If OSI is of the opinion that
such manufacture, use or sale would not infringe such patent owned by a third
party, OSI may, at its election, bring suit against such third party seeking a
declaration that such patent is invalid or not infringed by Wyeth's manufacture,
use or sale of the Licensed Human Therapeutic Product involved, or may bring
opposition, nullity or other proceedings against such patent, as appropriate. If
OSI is successful in such suit, Wyeth shall continue to pay royalties in such
country as provided in Section 3. If OSI is unsuccessful in such suit, it shall
join Wyeth in an attempt to obtain a license under such patent, and fifty
percent (50%) of any payments made by Wyeth to such third party for such license
shall be deductible from royalty payments due from Wyeth to OSI as to the patent
and that country pursuant to this Agreement.
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5. Treatment of Confidential Information.
5.1 Confidentiality.
5.1.1 Wyeth and OSI each recognize that the other's
Confidential Information constitutes highly valuable proprietary, confidential
information. Wyeth and OSI each agree that during the term of this Agreement and
for five (5) years thereafter, they will keep confidential all Confidential
Information that is disclosed to them or to any of their Affiliates pursuant to
this Agreement. Neither Wyeth nor OSI nor any of their Affiliates shall use such
Confidential Information except as expressly permitted in this Agreement.
5.1.2 Wyeth and OSI acknowledge that the Wyeth and OSI
confidential Information is highly valuable, proprietary, confidential
information, and agree that any disclosure of Confidential Information to any
officer, employee or agent of the other or of any of its Affiliates shall be
made only if, and to the extent, necessary to carry out its responsibilities
under this Agreement and shall be limited to the maximum extent possible
consistent with such responsibilities. Each party agrees not to disclose the
other's Confidential Information to any third party under any circumstance
without written permission. Each party shall take such action, and shall cause
its Affiliates to take such action, to preserve the confidentiality of the
other's Confidential Information as it would customarily take to preserve the
confidentiality of its own confidential information. Each party, upon the
other's request, will return all the Confidential Information disclosed to it
pursuant to this Agreement, including all copies and extracts of documents
within sixty (60) days of the request after the termination of this Agreement.
5.1.3 OSI represents that all of its employees participating in
the Research
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Program who shall have access to Wyeth Confidential Information are bound by
agreements to maintain such information in confidence. Consultants will be
similarly bound.
5.2 Publication. Except as required to pursue patent protection,
the parties agree not to publish the results obtained in the course of the
Research Program unless mutually agreed in which case the results may be
submitted for publication following scientific review by the Research Committee
and subsequent approval by OSI's and Wyeth's managements.
6. Intellectual Property Rights.
6.1 Ownership. All OSI Technology and OSI Patent Rights shall be
owned solely by OSI regardless of whether such Technology or Patent Rights are
developed, conceived, discovered, or invented by employees of, or consultants
to, OSI solely or jointly with employees or, or consultants to, Wyeth. All Wyeth
Technology and Wyeth Patent Rights shall be owned solely by Wyeth regardless of
whether such Technology or Patent Rights are developed, conceived, discovered,
or invented by employees of, or consultants to, Wyeth solely or jointly with
employees of, or consultants to, OSI.
6.2 Filing, Prosecution and Maintenance of Patent Rights. OSI shall
have the exclusive right, at its expense and in its sole discretion to file,
prosecute, defend, enforce, and maintain OSI Patent Rights. Wyeth shall have the
exclusive right, at its expense and in its sole discretion to file, prosecute,
defend, enforce and maintain Wyeth Patent Rights.
6.3 Consultation Concerning Patent Rights. OSI and Wyeth shall
each provide to the other copies of all patent applications within OSI Patent
Rights or Wyeth Patent Rights, respectively, which relate to the Targets prior
to filing such applications for the purpose of obtaining substantive comments of
the other's patent counsel. Each party shall provide to the
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other copies of all documents relating to prosecution of such patent
applications in a timely manner. Each party shall provide to the other every six
(6) months a reporting detailing the status of all such patent applications.
7. Termination by Wyeth
7.1 Wyeth may terminate this Agreement at any time without cause by
giving OSI at least six (6) months notice prior to the termination date. Such
termination will not affect the rights and obligations of the parties accrued
prior to the termination, including the right of OSI to receive royalties on
subsequent sales of Licensed Human Therapeutic Products, and OSI shall be
entitled to an exclusive license under Wyeth Patent Rights and Wyeth Technology
in the Target area(s) on the same terms under which Wyeth is exclusively
licensed under OSI Patent Rights and OSI Technology as provided for in this
Agreement.
7.2 Events of Termination. The following events shall constitute
events of termination ("Events of Termination"):
(a) any representation or warranty by OSI or Wyeth, or any of
its officers, under or in connection with this Agreement shall prove to have
been incorrect in any material respect when made;
(b) OSI or Wyeth shall fail in any material respect to perform
or observe any term, convent or understanding contained in this Agreement or in
any of the other documents or instruments delivered pursuant to, or concurrently
with, this Agreement, and any such failure shall remain unremedied for thirty
(30) days after written notice to the failing party.
7.3 Termination.
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7.3.1 Upon the occurrence of any Event of Termination, the
party not responsible may, by notice to the other party, terminate this
Agreement.
7.3.2 If Wyeth terminates this Agreement pursuant to Section
9.4.1, the License Agreements shall continue according to their terms. If OSI
terminates this Agreement pursuant to Section 9.4.1, the License Agreements
shall also terminate.
8. Representation and Warranty.
OSI and Wyeth represent and warrant to each other that they have the
right to grant to each other the licenses granted to then pursuant to this
Agreement, and that the licenses so granted do not conflict with or violate the
terms of any agreement between either of them and any third party.
9. Notices. All notices shall be mailed via certified mail, return receipt
requested, or courier, addressed as follows, or to such other address as may be
designated from time to time:
If to Wyeth: To Wyeth at its address as set forth at the beginning
of this Agreement
Attention: President,
Wyeth-Ayerst International, Inc.
with copy to: Office of the General Counsel
If to OSI: To OSI at its address as set forth at the beginning of
this Agreement
Attention: President
Notices shall be deemed given as of the date of receipt.
10. Governing Law. This Agreement shall be construed in accordance with
the laws of the State of New York.
11. Miscellaneous.
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11.1 Binding Effect. This Agreement shall be binding upon and inure
to the benefit of the parties and their respective legal representatives,
successors and permitted assigns.
11.2 Headings. Paragraph headings are inserted for convenience of
reference only and do not form a part of this Agreement.
11.3 Counterparts. This Agreement may be executed simultaneously in
two or more counterparts, each of which shall be deemed an original.
11.4 Amendment; Waiver; etc. This Agreement may be amended,
modified, superseded or canceled, and any of the terms may be waived, only by a
written instrument executed by each party or, in the case of waiver, by the
party or parties waiving compliance. The delay or failure of any part at any
time or times to require performance of any provision shall in no manner affect
its rights at a later time to enforce the same.
11.5 No Third Party Beneficiaries. No Person not a party to this
Agreement, including any employee of any party to this Agreement, shall have or
acquire any rights by reason of this Agreement. Nothing contained in this
Agreement shall be deemed to constitute the parties partners with each other or
any Person.
11.6 Assignment and Successors. This Agreement may not be
assigned by either part, in whole or in part, except to an Affiliate, to a
purchaser of all or substantially all of its assets or to any successor
corporation resulting from any merger or consolidation with or into such
corporation.
12. Wyeth-Ayerst International, Inc., as an Agent of American Home Products
Corporation
American Home Products Corporation hereby appoints Wyeth-Ayerst
International,
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Inc., as its sole and exclusive agent during the term of this Agreement for the
purpose of administrating on its behalf the rights and obligations under this
Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
AMERICAN HOME PRODUCTS CORPORATION
By_______________________________
Title_____________________________
ONCOGENE SCIENCE, INC.
By_____________________________
Title____________________________
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